Sleeve Gastrectomy Versus Medical Management for Remission of Diabetes in Mild to Moderately Obese Patients - Full Text View

Purpose

The investigators plan to randomize mild to moderately obese (BMI 30-34.9) subjects to medical management (diet, exercise, and best medical therapy) versus sleeve gastrectomy with medical management, with a primary endpoint of diabetes remission (normal fasting glucose, off medications and insulin) at one year. Sleeve gastrectomy (also called greater curvature gastrectomy, vertical sleeve gastrectomy, and sleeve gastroplasty) involves stapled resection of the gastric fundus. Secondary endpoints include weight loss, improvement in hypertension, sleep apnea, c-reactive protein, and fasting lipid profile.

Condition	Intervention
Diabetes Mellitus, Type 2 Obesity	Procedure: Laparoscopic sleeve gastrectomy Behavioral: Intensive medical management

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Sleeve Gastrectomy vs Medical Management for Remission of Diabetes in Mild to Moderately Obese Patients

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 2 Exercise and Physical Fitness Obesity Weight Control

U.S. FDA Resources

Further study details as provided by Wilford Hall Medical Center:

Primary Outcome Measures:

Diabetes remission [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Weight loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Obstructive sleep apnea remission [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Fasting lipid profile [ Time Frame: 1 year ] [ Designated as safety issue: No ]
c-reactive protein [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	August 2009
Estimated Study Completion Date:	September 2014
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Intensive medical management of Type 2 DM Intensive medical management of Type II diabetes will include visits every three months for a year with an endocrinologist, with lifestyle counseling, weight management, regular exercise, and glucose control forming the core of the medical therapy.	Behavioral: Intensive medical management Intensive medical therapy for Diabetes mellitus, Type 2, will include weight management counseling, exercise, glucose control, and healthy dietary choices.
Experimental: Laparoscopic sleeve gastrectomy Laparoscopic sleeve gastrectomy is performed as part of a bariatric surgical program emphasizing healthy dietary choices, regular exercise, and glucose control.	Procedure: Laparoscopic sleeve gastrectomy Laparoscopic sleeve gastrectomy, also known as vertical sleeve gastrectomy, sleeve gastroplasty, or sleeve gastrectomy, will be performed over a 32 to 40 French sizing bougie.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diabetes mellitus, Type 2
Body Mass Index (BMI) 30-34.9
Able to understand and comply with study process

Exclusion Criteria:

Pregnancy
Prior bariatric surgery
Diabetes mellitus, Type 1
Renal impairment
Cirrhosis or portal hypertension
Diabetes secondary to a specific condition
Recent internal malignancy (<5 years)
Recent major vascular event
Drug or alcohol dependence
Uncontrolled psychiatric disease
Crippling cardiopulmonary disease
Prohibitive anatomic features (extensive prior surgery, giant paraesophageal hernia)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965302

Locations

United States, Texas
Wilford Hall Medical Center
San Antonio, Texas, United States, 78236

Sponsors and Collaborators

Wilford Hall Medical Center

Investigators

Principal Investigator:

Jason M Pfluke, MD

Wilford Hall Medical Center, United States Air Force

More Information

Publications:

O'Brien PE, Dixon JB, Laurie C, Skinner S, Proietto J, McNeil J, Strauss B, Marks S, Schachter L, Chapman L, Anderson M. Treatment of mild to moderate obesity with laparoscopic adjustable gastric banding or an intensive medical program: a randomized trial. Ann Intern Med. 2006 May 2;144(9):625-33. Summary for patients in: Ann Intern Med. 2006 May 2;144(9):I12.

Kakoulidis TP, Karringer A, Gloaguen T, Arvidsson D. Initial results with sleeve gastrectomy for patients with class I obesity (BMI 30-35 kg/m2). Surg Obes Relat Dis. 2009 Jul-Aug;5(4):425-8. Epub 2008 Sep 26.

Lee CM, Cirangle PT, Jossart GH. Vertical gastrectomy for morbid obesity in 216 patients: report of two-year results. Surg Endosc. 2007 Oct;21(10):1810-6. Epub 2007 Mar 14.

Dixon JB, O'Brien PE, Playfair J, Chapman L, Schachter LM, Skinner S, Proietto J, Bailey M, Anderson M. Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial. JAMA. 2008 Jan 23;299(3):316-23.

Cohen R, Pinheiro JS, Correa JL, Schiavon CA. Laparoscopic Roux-en-Y gastric bypass for BMI < 35 kg/m(2): a tailored approach. Surg Obes Relat Dis. 2006 May-Jun;2(3):401-4, discussion 404.

Responsible Party:	Jason M. Pfluke, MD MAJ USAF MC, Wilford Hall Medical Center, United States Air Force
ClinicalTrials.gov Identifier:	NCT00965302 History of Changes
Other Study ID Numbers:	FWH20090068H
Study First Received:	August 24, 2009
Last Updated:	December 19, 2012
Health Authority:	United States: Federal Government

Keywords provided by Wilford Hall Medical Center:

Obesity
Diabetes mellitus, Type 2
Sleeve gastrectomy
Metabolic surgery

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013